Solicitation Attachment - SOW Dose Calibrator.docx

Syracuse VA Medica Center 800 Irving Ave.

Syracuse, NY 13210

Statement of Work

Purpose:

The Syracuse VA Medical Center has a requirement to purchase (1) Dose Calibrator with Well Counter (Includes: Well Liner, Vial/Syringe Dipper, Instruction Manual) to supply and deliver the items identified in Table 1 below. This is a Brand Name or Equal requirement; refer to the salient characteristics below. MIRION TECHNOLOGIES is the basis of design and the CRC-55TW is the model of Dose Calibrator we evaluated.

Table 1 – Package Item(s) Summary

Includes:

*Well Liner *Vial/Syringe Dipper *Instruction Manual

Scope of Work:

Equipment will be shipped in original OEM packaging and will be inspected upon receipt to ensure equipment is free of defect and/or damage. The equipment will ship complete, no partial shipments will be accepted.

Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.

The vendor will provide all applicable service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA Biomedical Engineering Department.

Period of Performance:

This will be a firm fixed contract with an estimated lead time for delivery is approximately 60 days.

Delivery Instructions:

Delivery Hours of Operation: Monday – Friday; 0700hrs – 1500hrs; excluding all Federal Holidays.

Inspection:

Prior to acceptance of the goods or services provided under this contract, inspection and testing will be performed by the government.

Warranty:

The Contractor shall provide all manufacturer’s warranty with products upon delivery. Warranty shall commence upon acceptance by VA representative and verification of operational functionality.

The warranties shall include all travel and shipping costs associated with any warranty repair.

Deliverables:

Operation and Maintenance Manuals Invoicing and Supporting Documentation:

The supporting documentation and invoice shall be submitted within 30 days at the end of each month. Subsequent changes or corrections shall be submitted by a separate invoice. In addition to information required for submission of a ‘proper’ invoice in accordance with FAR 52.212-4 (g), all invoices must include the following information:

a. Name and Address of Contractor

b. Contractor’s Tax Identification Number

c. Date of Invoice

d. Invoice Number

e. Contract Number

f. Purchase Order Number

g. Date of Service

h. Contract Line Item Number (CLIN)

i. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of the items delivered

j. Total Price Recalls:

The Vendor shall immediately notify all affected VA Medical Centers and designated POC in the event of a device recall, removal, required adjustment, or required modification that is suggested or mandated by the Vendor, distributor, manufacturer, or any regulatory or government agency. The following information shall be included in this notification:

A complete item description and identification (to include lot or serial numbers where applicable); administrative identification data including order numbers and order date; reasons for recall, removal, adjustment, or modification; and Instructions for appropriate corrective action.

Confidentiality and Non-Disclosure:

This equipment does not connect to a VA network. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, Block 6, the C&A requirements do not apply to this requirement, and a Security and Accreditation Package in not required.

This equipment does not hold or store patient information. Therefore, in accordance with Appendix A, Handbook 6500.6 Checklist, Block 7, Appendix B and C provisions do not apply.

Salient Characteristics:

Total Quantity: 1 ☐ Network Required if Checked ☐ Manufacturer Certified Installation Required if Checked ☐ BMET Training Required if Checked ☐ End User Training Required if Checked

Basis of Design is MIRION TECHNOLOGIES, MFG P/N: CRC-55TW & RS-232

Dose Calibrator & Well Counter

· Should include a VGA touch screen color display of at least 8in.

· Needs USB/PC communication compatibility.

· Should be capable of receiving software upgrades via USB or Flash Drive.

· Should have chamber plug-and-play capability.

· Minimum 28 programmable nuclide keys.

· Have built-in dose calibration, quality control and self-diagnostics.

· Minimum 80 nuclides in memory.

· Automatic chamber QC including linearity.

· Capable of providing hard copy records of data available from current printer.

· Compatible with nuclear medicine information management systems (NMIS) via USB.

· Include 256 channel MCA with detailed spectrum for identification analysis.

· Compatible with current Cs-137 Calibration Source (Product code SRV-137-200U, Activity 213.2 uCi, S/N 2324-57-7, Ref. Date 2023-03-01.)

· Compatible with inner and outer dimensions of our current lead shielding: Outer 444mm, Inner 170mm, Wall Thickness 50mm.

· Be compatible with current well: dimensions 280mm H x 69mm dia.

· Include a well counter for wipe tests

· Must include user-definable protocols for wipe testing

· Must have an automated well QC including Chi-Square and MDA.

· Needs manual and Automatic ROI

· Able to report the following: Well counter reports for autocalibration, system test, MDA, and Chi-Square are archived and searchable by date, type, and activity

· Include Automated Linearity Testing and Geometry Testing

· Ionization Chamber features should include: Fill Gas: 12 atm Ultra High Purity Argon; Measurement: Auto ranging; Activity Range: Up to 6 Ci (250 GBq); Resolution: .001 MBq (.01 µCi);

· Response Time: Within 2 sec, for low activity sample, 4 to 16 sec; Tests: Daily tests include Auto Zero, Background Adjustment, Voltage Test, Data Check, Accuracy and Constancy; Enhanced QC includes linearity, geometry, strip QC

· Electrometer should meet the following criteria: Accuracy: Better than ± 2%; Linearity: Within ± 2%

· Repeatability of Measurement should be within ± 1% within 24 hours during which time the calibrator is continuously in operation

· Nuclide Data: 28 programmable keys; System Memory: Over 80 nuclides (cal number and half-life); A pre-set key measures up to 2.0 Ci (74.0 GBq) of F-18

· System Memory should meet the following: Co-57, Co-60, Ba-133, Cs-137

· Molybdenum-99 Assay: Methods: CAP-MAC canisters; Measured Values: Mo-99 elution, Tc-99m, Tc-99m/Mo-99 ratio

· Interface should be compatible to the following: RS-232 and USB; Compatibility: Standard Nuclear Medicine Management Systems; Ethernet interface

· Printer Compatibility should meet the following: RS-232 and USB Ports on well, SCSSI on printer.; Epson Roll, Epson Slip or Okidata dot matrix

· Power Requirements within: 100-240 V ac (50/60 Hz) 100 MA

· Tests: Diagnostics: Full test of program, system memories